MedPath

Meloxicam

Generic Name
Meloxicam
Brand Names
Anjeso, Mobic, Qmiiz, Vivlodex
Drug Type
Small Molecule
Chemical Formula
C14H13N3O4S2
CAS Number
71125-38-7
Unique Ingredient Identifier
VG2QF83CGL

Overview

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve various types of pain, including pain caused by musculoskeletal conditions, osteoarthritis, and rheumatoid arthritis. With a longer half-life than most other NSAIDS, it is a favorable option for those who require once-daily dosing. Meloxicam is available in oral, transdermal, and intravenous formulations. It is a preferential COX-2 inhibitor, purportedly reducing the risk of adverse gastrointestinal tract effects, however, this is a topic of controversy.

Indication

Meloxicam is indicated for the symptomatic treatment of arthritis and osteoarthritis. In addition, it is indicated for the pauciarticular and polyarticular course of Juvenile Rheumatoid Arthritis (JRA) in patients aged 2 years old or above. Off-label uses include the treatment of dental or post-surgical pain. In addition to the above, meloxicam has also been studied in the treatment of neuropathic pain. Meloxicam, in combination with bupivacaine, is indicated for postsurgical analgesia in adult patients for up to 72 hours following foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.

Associated Conditions

  • Dental Pain
  • Neuropathic Pain
  • Osteoarthritis (OA)
  • Pain, Inflammatory
  • Pauciarticular juvenile rheumatoid arthritis
  • Polyarticular juvenile rheumatoid arthritis, chronic or unspecified
  • Postoperative pain
  • Rheumatoid Arthritis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/01
Phase 3
Completed
2024/11/25
Phase 4
Not yet recruiting
2024/04/23
Phase 3
Completed
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2024/03/12
Phase 2
Recruiting
2023/08/03
Phase 4
Completed
2023/07/18
Phase 2
Not yet recruiting
2023/01/25
Phase 2
Recruiting
2022/04/07
Phase 4
Terminated
Baudax Bio
2022/03/22
Phase 3
Completed
2021/10/28
Not Applicable
Completed
Alfarabi Colleges

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Exelan Pharmaceuticals Inc.
76282-153
ORAL
15 mg in 1 1
2/17/2023
Carlsbad Technology, Inc.
61442-126
ORAL
7.5 mg in 1 1
2/17/2023
STERLING KNIGHT PHARMACEUTICALS, LLC
69336-102
ORAL
15 mg in 1 1
12/30/2015
Northwind Pharmaceuticals, LLC
51655-571
ORAL
15 mg in 1 1
1/25/2023
REMEDYREPACK INC.
70518-1299
ORAL
7.5 mg in 1 1
2/15/2024
AiPing Pharmaceutical, Inc
11788-047
ORAL
15 mg in 1 1
10/6/2023
Belcher Pharmaceuticals,LLC
62250-676
ORAL
15 mg in 1 1
6/30/2015
REMEDYREPACK INC.
70518-1630
ORAL
15 mg in 1 1
6/23/2025
Advanced Rx Pharmacy of Tennessee, LLC
80425-0043
ORAL
7.5 mg in 1 1
11/10/2022
Dispensing Solutions, Inc.
66336-774
ORAL
15 mg in 1 1
7/3/2013

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
Arrox Tablet 7.5mg
SIN14305P
TABLET
7.50mg
1/31/2013
MOBIC TABLET 7.5 mg
SIN09554P
TABLET
7.5 mg
11/28/1997
MELOX TABLET 7.5 mg
SIN12127P
TABLET
7.5 mg
11/20/2002

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
MELFLAM-7.5 TAB 7.5MG
N/A
N/A
N/A
3/14/2005
NEWSICAM CAP 15MG
N/A
N/A
N/A
2/8/2010
MEDICON CAPSULE 7.5MG
N/A
N/A
N/A
8/7/2014
MOCAM TABLETS 7.5MG
N/A
N/A
N/A
10/3/2019

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
MYLAN-MELOXICAM
Mylan Pharmaceuticals ULC
02255995
Tablet - Oral
15 MG
8/11/2004
PHL-MELOXICAM
pharmel inc
02248607
Tablet - Oral
7.5 MG
4/6/2004
ZYNRELEF
02525968
Solution (Extended Release) - Instillation
1.8 MG / 2.3 ML
N/A
ZYNRELEF
02526026
Solution (Extended Release) - Instillation
9 MG / 10.5 ML
N/A
ZYNRELEF
02526034
Solution (Extended Release) - Instillation
12 MG / 14 ML
N/A
AVA-MELOXICAM
avanstra inc
02365545
Tablet - Oral
7.5 MG
11/8/2011
RATIO-MELOXICAM
ratiopharm inc division of teva canada limited
02247889
Tablet - Oral
7.5 MG
11/11/2003
NU-MELOXICAM
nu-pharm inc
02335514
Tablet - Oral
15.0 MG
N/A
TEVA-MELOXICAM
teva canada limited
02258323
Tablet - Oral
15 MG
10/22/2004
PHL-MELOXICAM
pharmel inc
02248608
Tablet - Oral
15 MG
4/6/2004

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
MOVALIS 7,5 mg COMPRIMIDOS
61075
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MELOXICAM NORMON 7,5 mg COMPRIMIDOS EFG
Laboratorios Normon S.A.
69365
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MOVALIS 15 mg/1,5 ml SOLUCION INYECTABLE
Boehringer Ingelheim Espana S.A.
64313
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
MELOXICAM STADA 7.5 mg COMPRIMIDOS EFG
Laboratorio Stada S.L.
66399
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MELOXICAM UR 15 mg COMPRIMIDOS EFG
Aristo Pharma Iberia S.L.
67384
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
MELOXICAM CINFA 15 mg COMPRIMIDOS EFG
Laboratorios Cinfa S.A.
69094
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MELOXICAM PENSA 7,5 mg COMPRIMIDOS EFG
Towa Pharmaceutical S.A.
68843
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MELOZALTAN 15 MG COMPRIMIDOS EFG
Zaltanpharma Laboratorios S.L.
68797
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
MELOXICAM MYLAN 15 mg COMPRIMIDOS EFG
Mylan Pharmaceuticals S.L.
66410
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
MELOXICAM NORMON 15 mg COMPRIMIDOS EFG
Laboratorios Normon S.A.
69366
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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